Kornimate/medical-research-clean huggingface dataset:
hiv-hcv coinfection: impact of immune dysfunction

Conditions: HIV Infections; Hepatitis

Summary: effective therapy for human immunodeficiency virus (hiv) infection has markedly prolonged survival in infected individuals. as a result, other diseases are now becoming clinically significant. approximately 30% of hiv infected patients are co-infected with hepatitis c virus (hcv) which is now the leading co-morbid disease in co-infected individuals. the histologic severity and natural history of hcv has been reported to be accelerated in those co-infected with hiv. it is hypothesized that 1) the severity and progression of hcv disease is related to the immune competence of the individual, 2) immune restoration associated with hiv therapy may further accelerate the progression of hcv disease which may explain the marked increase in hcv related morbidity and mortality observed in recent years, and 3) the virologic response to anti-hcv treatment is directly related to the degree of immunologic competence. the specific aims of the proposal are: 1) to obtain, through multi-disciplinary didactic teaching, the necessary skills of clinical research design, data collection, data analysis, and biostatistical methods and 2) to study the impact of hiv disease on hcv, the effect of the immune function and immune restoration during hiv therapy on the natural history of hcv, and the efficacy of hcv treatment in hiv co-infection.

approximately 30% of hiv infected patients are co-infected with hepatitis c virus (hcv) which is now the leading co-morbid disease in co-infected individuals. the histologic severity and natural history of hcv has been reported to be accelerated in those co-infected with hiv. it is hypothesized that 1) the severity and progression of hcv disease is related to the immune competence of the individual, 2) immune restoration associated with hiv therapy may further accelerate the progression of hcv disease which may explain the marked increase in hcv related morbidity and mortality observed in recent years, and 3) the virologic response to anti-hcv treatment is directly related to the degree of immunologic competence. the specific aims of the proposal are: 1) to obtain, through multi-disciplinary didactic teaching, the necessary skills of clinical research design, data collection, data analysis, and biostatistical methods and 2) to study the impact of hiv disease on hcv, the effect of the immune function and immune restoration during hiv therapy on the natural history of hcv, and the efficacy of hcv treatment in hiv co-infection.

Eligibility criteria:
inclusion criteria: * hiv antibody positive * positive hcv-rna * age \> 18 years exclusion criteria: * coagulopathy (prothrombin time prolonged \> 2 seconds from control) * presence of ascites * thrombocytopenia (platelet \< 70,000) * active or recent (within 3 months) opportunistic infection related to hiv * advanced hiv disease with life expectancy less than 1 year * renal failure * hepatitis b surface antigen positive * inability to give informed consent

Keywords: hiv-hcv coinfection hiv histology
timing of re-evaluation after steps i-ii of periodontal therapy

Conditions: Periodontitis

Summary: literature on non surgical periodontal therapy (nspt) shows lack of clarity in reporting information on re-evaluation timing and clinical response. if the re-evaluation was done shortly after nspt, this is also likely to have an influence on the surgical treatment plan. the aim of this randomized clinical trial is to investigate the effect of re-evaluation timing at 1-3-6 months after nspt in terms of pocket closure, probing pocket depth reduction, comprehensive treatment plan, and costs for the patient.


Eligibility criteria:
inclusion criteria: * periodontitis stage iii-iv * full-mouth plaque score (fmps) \< 25% at the 1-month re-evaluation * full-mouth bleeding score (fmbs) \< 25% at the 1-month re-evaluation * signed informed consent exclusion criteria: * age \< 18 yo * pregnancy or lactation * heavy smokers (\>10 die) * conditions or diseases influencing periodontal healing * patients that cannot complete the 6 months follow-up
use of tranexamic acid in the total knee arthroplasty.

Conditions: Knee Osteoarthritis; Blood Loss; Blood Transfusion

Summary: tranexamic acid is a medication used to treat or prevent excessive blood loss during surgery. previous studies have shown tranexamic acid (txa) reduces blood loss and post-operative blood transfusion rate without significant complications. in addition, many meta-analyses have confirmed these results. this study also aims to determine how safe and effective tranexamic acid treatment is for different patients undergoing primary total knee arthroplasty.

tranexamic acid (txa) is used to control both intraoperative (io) and postoperative (po) bleeding during various surgical procedures. moreover, txa was found to indirectly reduce post-surgery infection rates and decrease hemorrhage-related mortality in trauma patients. this study aims to determine how safe and effective tranexamic acid treatment is for patients undergoing primary total knee arthroplasty. the study is a prospective, randomized, triple-blinded, placebo-controlled study. ninety participants were enrolled between july 2021 and september 2022 and followed up with every patient for six months. the study was done in damascus, syria. participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 groups. the allocation was put into concealed envelopes independent of the surgeon and the author, and the randomization was performed by a research fellow who was not involved in patient care. participants who went unilateral primary tka and did not use txa, just iv normal saline (0.9% sodium chloride), formed the control group. in contrast, the intervention group comprised participants who went primary unilateral tka and used two-dose intravenous tranexamic acid that was applied as follows: 10mg/kg of tranexamic acid in 100 milliliters（ml) normal saline (0.9% sodium chloride), the first dose 15 minutes before the tourniquet deflation and the second dose at 180 minutes after the first dosage.

Eligibility criteria:
inclusion criteria: * patients with primary knee osteoarthrosis who underwent unilateral primary tka exclusion criteria: * known allergic reaction to tranexamic acid * secondary arthritis (ex., rheumatic arthritis, traumatic arthritis, septic arthritis) * bmi less than 20 and more than 40. * patients having vascular or hematologic disease. * patients who were taking anti-coagulant medicine and couldn't stop it. * patients having acute or chronic renal failure. * patients classified as the aaa as grade four or five. * patients with intra-operative complications such as intra-operative fractures or vascular injuries. * post-traumatic and secondary knee arthritis patients. * revisions and complex primary cases. * patients with an active infection or a history of lower limp infection.

Keywords: tranexamic acid total knee arthroplasty blood loss complication
sublingual methadone for the management of cancer-related breakthrough pain in outpatients

Conditions: Cancer; Pain

Summary: the purpose of this phase ii study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population before conducting an appropriately powered phase iii study. thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an optimal dose of sublingual (under the tongue) methadone and then studied at that optimal dose with successive episodes of breakthrough pain.


Eligibility criteria:
inclusion criteria: * pain due to cancer or its treatment; controlled baseline pain; * episodes of breakthrough pain every day that are "4/10" in severity or greater, ; * ast 10 minutes or longer, and * are responsive to short acting oral opioids such as morphine or hydromorphone; * are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent; * are able to fill out the study forms exclusion criteria: * severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid; * prior sensitivity to methadone; * currently are being administered methadone; * have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain, * new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain); * are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely

Keywords: sublingual methadone cancer related breakthrough pain feasibility study phase ii/open label outpatients safety/ efficacy previously receiving opioids speak english
clinical comparison of rpds retained by conical and galvanoformed double crowns.

Conditions: Denture, Partial, Removable; Dental Prosthesis Retention; Oral Health; Tooth Abrasion

Summary: the aim of this prospective clinical trial was to investigate the clinical performance and complication rate of rpds (removable partial dentures) retained on conventional conical double crowns in comparison to galvanoformed telscopic double crowns. additionally the ohip (oral health related qualitiy of life)and the abrasion of the teeth were investigated.


Eligibility criteria:
inclusion criteria: * indication for rpds retained by double crowns; 2 to 6 abutment teeth; exclusion criteria: * limited contractual capability and absence of consent of the patient
differences in timely cancer diagnosis in african american and caucasian patients with newly diagnosed colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: gathering information about timely diagnosis in african american and caucasian patients with newly diagnosed colorectal cancer may help doctors learn more about factors that influence a diagnosis and plan the best treatment. purpose: this phase i trial is studying differences in timely cancer diagnosis in african american patients and in caucasian patients with newly diagnosed colorectal cancer.

objectives: * identify and examine the factors that influence appraisal and diagnostic delay by focusing on recognition, perception, communication, and response to pre-diagnosis cancer symptoms in african american and caucasian patients with newly diagnosed colorectal cancer. outline: this is a multicenter study. patients are stratified according to race (african-american vs caucasian) and gender (male vs female). patients undergo a 45-60 minute interview to obtain information on variations in symptom perception, assessment, and patient-physician communication process. patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity), information of close confidants (i.e., relationship, family history of cancer, and caregiver/decision-making status), and physician characteristics. patients are also assessed by the trust in the health care system, dmpq, rcs, brief cope scale, lukwago religiosity scale, and rand social support survey questionnaires. patient charts are reviewed to obtain medical data.

Eligibility criteria:
inclusion criteria: * 21 years of age or older * cognitively able to participate in an interview * diagnosed with colorectal cancer * patient at university hospitals, case western reserve university, or cleveland clinic foundation * diagnosed within 6 months of the scheduled interview * have no prior history of colon cancer or cancer of any other major organ system * any stage of cancer * patient will have described their symptoms to their pcps * patient will have acted as their own decision maker * must be african american or caucasian exclusion criteria * no disease discovered by previous routine screening or by other unintentional detection procedure (i.e., without symptom appraisal process or communicating specific symptoms to physicians) * not living in nursing or assisted living facilities * cognitive impairment

Keywords: stage i colon cancer stage ii colon cancer stage iii colon cancer stage iv colon cancer stage i rectal cancer stage ii rectal cancer stage iii rectal cancer stage iv rectal cancer
registry of angiojet use in the peripheral vascular system

Conditions: Peripheral Vascular Disease; Embolism and Thrombosis; Venous Thrombosis

Summary: the registry involves the collection of information for research and educational purposes only on the use of angiojet in the peripheral vascular system.

the pearl ii registry is a prospective, multi-center, observational registry including 500 patients who meet eligibility from up to 50 sites worldwide. patient participation will be 12 months including post procedure follow-up contact at 3, 6 and 12 months. the study duration is estimated at 36 months. a patient's treatment is determined by the treating physician based on the clinical situation and local practices. in contrast to a randomized, controlled trial, there are no pre-defined experimental interventions.

Eligibility criteria:
inclusion criteria: * patient has been treated in the peripheral vascular system with any of the angiojet system catheters. * patient has provided appropriate consent/authorization per the site's institutional policy and procedure. exclusion criteria: * patient has previously been enrolled in either the pearl registry or the pearl ii registry in the last 12months.
advanced mri sequences for radiation therapy treatment planning

Conditions: Cancer

Summary: the purpose of this study is to determine if it would be helpful to use advanced mri imaging techniques to take additional views of the tumor target for radiation treatment planning or treatment follow-up mri.

the results of this research project will be used to establish a standard mri protocol specific to each tumor or disease site. an mri protocol is a list of mr image types that are acquired for each disease site. these images are used to generate the patient's treatment plan.

Eligibility criteria:
inclusion criteria: * patients aged 18 years older of any race or gender with anal canal, brain, breast, cervix, esophagus, gynecology, head and neck, lung, pancreas, primary liver or liver metastases, prostate cancer or sarcoma either undergoing mri scan for radiation treatment planning or a post treatment mri * voluntarily signs an irb approved consent form exclusion criteria: * inability to obtain informed consent from the patient or their medical power of attorney * patients who are not undergoing mr for radiation treatment planning * patients who will not have mri scans after treatment * patients with pacemakers or other non-mri compatible metallic implants * pregnant women, by self report using a standard mri questionnaire * patients who will not receive contrast agent as part of their standard mr, will participate only in the non-contrast portion of the study

Keywords: anal canal brain breast cervix esophagus gynecology head and neck lung pancreas primary liver or liver metastases prostate cancer sarcoma
challenge test for acetylsalicylic acid hypersensitivity

Conditions: Asthma Aspirin-sensitive; ASA Intolerant Asthma; Asthma, Aspirin-Induced; Asthma, Nasal Polyps, and Aspirin Intolerance

Summary: the investigators want to find new challenge test for acetylsalicylic hypersensitivity / aspirin hypersensitivity. the investigators suggest that this new test will be as efficient as the already established protocols in terms of sensitivity and specificity.

hypersensitivity to acetylsalicylic acid or aspirin (and other nsaids) is a condition that affects up to 2,5% of the population. most cases are seen in a complex of such hypersensitivity with chronic eosinophilic rhinosinusitis with nasal polyposis and asthma. despite research in finding a reliable in-vitro-test for the condition, challenge tests are still considered gold standard. so far oral, nasal, inhalation and intravenous routes of administration has been described in literature.

Eligibility criteria:
inclusion criteria: * persons between 18 and 60 years of age * suspected acetylsalicylic acid hypersensitivity exclusion criteria: * history on anaphylactic shock after nsaids intake * history on gastric ulcer after nsaids intake * patients previously gone through testing or desensitisation for aspirin hypersensitivity * clinical unstable asthma or baseline fev1\<70% * severe disease of the heart, digestive tract, liver or kidney * severe chronic urticaria * present conjunctivitis * pregnancy

Keywords: challenge test for aspirin hypersensitivity challenge test for acetylsalicylic hypersensitivity
immunogenicity and safety of concomitant administration of rotateq™ (v260) and the diphtheria, tetanus, pertussis and inactivated poliovirus vaccine (dtp-ipv) in healthy japanese infants (v260-060)

Conditions: Rotavirus Disease

Summary: the study will evaluate the immunogenicity of the diphtheria, tetanus, pertussis and inactivated poliovirus vaccine (dtp-ipv) with concomitant administration of rotateq™ (v260) in healthy japanese infants. the hypothesis to be tested is that the antibody response rates to dtp-ipv with concomitant administration of rotateq™ are non-inferior to those with staggered administration of rotateq™.


Eligibility criteria:
inclusion criteria: * japanese participant * age 6 weeks through \<11 weeks (42 to 76 days from date of birth) at visit 1 exclusion criteria: * history of hypersensitivity and/or anaphylaxis to any of the product ingredients in v260 or dtp-ipv * gastrointestinal disorder, growth retardation, or failure to thrive * history of intussusception * untreated congenital gastrointestinal disorder (such as meckel diverticulum) * known or suspected impairment of immunological function, including severe immunodeficiency (scid) * cardiovascular, renal, liver, or blood disease * history of convulsion * undergoing immunosuppressive therapy or living with a close relative with congenital immune deficiency * prior vaccination with rotavirus vaccine and/or dtp-ipv vaccine * live vaccine received within 28 days or inactivated vaccine received within 7 days * at high risk for tuberculosis exposure
pleural effusion following cardiac surgery: prevalence, risk factors and clinical features

Conditions: Pleural Effusion; Coronary Artery Bypass

Summary: pleural effusion is a common complication of cardiac surgery. the aim of this study was to determine the prevalence, characteristics and determinants of clinically significant pleural effusions, defined as those requiring therapeutic pleural drainage.

this was a retrospective cohort study of prevalence and characteristics of patients who had a pleural effusion after coronary artery bypass graft, valve replacement or both procedures. information was collected on all consecutive patients who underwent cabg surgery and/or valve replacement between january 1, 2004 and december 31, 2005. demographic information, anthropometric parameters, cardiac and renal function assessments, and comorbid conditions were retrieved from medical files. we also collected data on the type of procedure, whether it was elective or urgent, the number and origin of the grafts, the duration of surgery and of cardiopulmonary bypass and the postoperative complications, including pleural effusions. clinical presentation and evolution of the effusions as well as pleural fluid characteristics were also studied. patients were considered to have a clinically significant pleural effusion when they met at least one of the following criteria: need for thoracentesis, a pleural drainage tube or a hospital readmission due to a pleural effusion that occurred within one year of surgery.

Eligibility criteria:
inclusion criteria: * coronary artery bypass grafting (cabg) * valve replacement * combined cabg and valve replacement * between january 1st, 2004 and december 31st, 2005 exclusion criteria: * previous cabg * pulmonary and/or aortic artery surgery * heart or lung transplant * pleural effusion present at the time of surgery

Keywords: pleural effusion coronary artery bypass heart valve replacement
study evaluating etanercept treatment of patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the primary objective of the study was to compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the percentage of patients who achieve the assessment in ankylosing spondylitis (asas) response criteria (asas 20%) at week 12.


Eligibility criteria:
main inclusion criteria * diagnosis of as (defined by modified new york criteria for ankylosing spondylitis). * active as (defined by the average of scores on the visual analog scale \[vas\] of ≥ 30 for duration and intensity of morning stiffness and by 2 of the following: vas for patient global assessment ≥ 30; average of vas for nocturnal and total pain ≥ 30; basfi ≥ 30 (all scores on a scale of 0 to 100). * 18 to 70 years of age. main exclusion criteria * complete ankylosis (fusion) of spine. * previous receipt of etanercept, antibody to tumour necrosis factor alpha (tnfα), or other tnfα inhibitors. * use of disease-modifying antirheumatic drugs (dmards) other than hydroxychloroquine, sulphasalazine, or methotrexate within 4 weeks of baseline.
a safety study of nnz-2566 in pediatric rett syndrome

Conditions: Rett Syndrome

Summary: the purpose of this study is to determine whether nnz-2566 is safe and well tolerated in the treatment of rett syndrome in children and adolescents.

rett syndrome is a neurodevelopmental disorder primarily affecting females. the disorder is characterized by apparent normal development in early infancy (6-18 months), followed by a period of regression with onset of systemic and neurological signs. the cns symptoms of rett syndrome include learning disability, autism symptomatology and epilepsy and these can be severe and highly debilitating. affected individuals also show signs of autonomic dysfunction, reflected in cardiovascular and respiratory abnormalities. there is no currently effective treatment for rett syndrome. this study will investigate the safety, tolerability and blood pharmacokinetics of treatment with oral administration of nnz-2566 at 50 mg/kg, 100 mg/kg, 200 mg/kg bid, or placebo bid, in children and adolescent females with rett syndrome. the study also will also investigate measures of efficacy and biomarkers during treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of classic/typical rett syndrome with a documented mutation of the mecp2 gene. * age 5 - 15 years. * weight at screening and baseline between 15.0 kg-100.0 kg (at least 15.0 kg and no greater than 100.0 kg). * each subject must be able to swallow the study medication provided as a liquid solution, or via gastrostomy tube. exclusion criteria: * actively undergoing neurological regression * abnormal qt interval, prolongation or significant cardiovascular history. * current treatment with insulin. * anti-convulsants with liver enzyme inducing effects. * unstable seizure profile. * excluded concomitant medications. * current clinically significant (as determined by the investigator). cardiovascular, renal, hepatic, or respiratory disease. * gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication. * history of, or current cerebrovascular disease or brain trauma. * history of, or current clinically significant endocrine disorder, e.g. hypo- or hyperthyroidism, or diabetes mellitus. * history of, or current, malignancy. * significant hearing and/or visual impairments that may affect ability to complete the test procedures. * allergy to strawberry.

Keywords: autism rett's syndrome rett disorder rett's disorder ataxia